| Hearing Aid Feature (K261187) | Samsung Electronics Co., Ltd. | 2026-07-31 |
| SeptAlign (SPLN001) (K260620) | Spirair, Inc. | 2026-07-30 |
| MONARCH™ Platform (MON-000008) (K260382) | Auris Health, Inc. | 2026-07-25 |
| EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes (K261274) | Cook Ireland, Ltd. | 2026-07-24 |
| Ossiclear (Ossiclear System) (K254296) | Sounduct | 2026-07-22 |
| Hearing assist (K254044) | Meta Platform Technologies, LLC | 2026-07-13 |
| Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System (K260902) | Cochlear Americas | 2026-07-10 |
| LungFlow Airway Catheter (K254037) | Free Flow Medical, Inc. | 2026-07-10 |
| Jabra Enhance Select Self-fit (Jabra Enhance Select 550) (K254108) | GN Hearing A/S | 2026-06-25 |
| iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) (K260992) | Neuralytix | 2026-06-25 |
| Hydro Irrigation System (K261544) | Stryker Instruments | 2026-06-17 |
| FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T (K253137) | Fujifilm Corporation | 2026-06-16 |
| Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) (K260452) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 |
| Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) (K261256) | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 |
| Tinnitus Therapy (K260614) | Sivantos GmbH | 2026-06-10 |
| KARL STORZ Laryngoscopes and Accessories (K252624) | KARL STORZ Endoscopy-America, Inc. | 2026-05-15 |
| ENTity USB Videoscope System (K254133) | Optim, LLC | 2026-05-14 |
| SmartClip Delivery Catheter (ADR-1715) (K260565) | Elucent Medical | 2026-05-14 |
| Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) (K253580) | Tedan Surgical Innovations | 2026-04-26 |
| EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190) (K252341) | Olympus Medical Systems Corp. | 2026-04-23 |
| Tula Tympanostomy Tube Delivery Device (K252436) | Tusker Medical, Inc. | 2026-04-23 |
| ClearTip TBNA Type (K251478) | Finemedix Co., Ltd. | 2026-04-16 |
| LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) (K260420) | MacroLux Medical Technology Co., Ltd. | 2026-04-08 |
| mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) (K260718) | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 |
| mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 (K260719) | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 |
| mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (K260720) | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 |
| Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) (K253184) | Zhuhai Wesee Meditech Co., Ltd. | 2026-03-25 |
| Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D (K252050) | Olympus Medical Systems Corporation | 2026-03-20 |
| Tyto Insights for Eardrum Bulging Detection (DEN250014) | Tyto Care , Ltd. | 2026-03-17 |
| LungFlow Basket Catheter (K254040) | Free Flow Medical, Inc. | 2026-03-12 |
| LifeVac (DEN250012) | Lifevac, LLC | 2026-03-04 |
| KARL STORZ Mediastinoscopes and Instruments (K260003) | Karl Storz SE & CO. KG | 2026-03-02 |
| Evala Nerve Stimulator (EPNR002) (K253536) | Epineuron Technologies, Inc. | 2026-02-27 |
| Acclarent AERA Eustachian Tube Balloon Dilation System (K253612) | Acclarent, Inc. | 2026-02-19 |
| NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) (K251672) | Medtronic Xomed, Inc. | 2026-02-10 |
| SeptAlign (K251790) | Spirair, Inc. | 2026-01-16 |
| iotaSOFT® Insertion System (K252339) | Iotamotion, Inc. | 2026-01-09 |
| LIA-1 Catheter (542-1) (K251402) | Leadoptik, Inc. | 2025-12-19 |
| FUJIFILM Ultrasonic Endoscope EB-710US (K250863) | Fujifilm Corporation | 2025-12-12 |
| KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) (K251731) | Karl Storz SE & CO. KG | 2025-12-05 |
| Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 (K252874) | Serpex Medical, Inc. | 2025-10-08 |
| Tuned Self-Fitting Mobile App (K251208) | Tuned , Ltd. | 2025-09-26 |
| Radial Jaw 4 Pulmonary Biopsy Forceps (K252921) | Boston Scientific Corporation | 2025-09-26 |
| Ion Endoluminal System (IF1000) (K252045) | Intuitive Surgical, Inc. | 2025-09-23 |
| Himaging Bronchscope System (K251894) | Himaging Technology (Shanghai) Co., Ltd. | 2025-09-23 |
| Ion Endoluminal System (IF1000) (K252528) | Intuitive Surgical, Inc. | 2025-09-05 |
| Sunrise (K250874) | Sunrise SA | 2025-08-29 |
| Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (K251752) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-08-27 |
| Outlook Surgical Versa One System (8900139) (K241731) | Resnent, LLC | 2025-08-11 |
| UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S) (K251823) | Zhejiang UE Medical Corp. | 2025-08-11 |
| Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) (K251664) | Olympus Medical Systems Corporation | 2025-07-29 |
| Vathin® Video Bronchoscope System (K250232) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-25 |
| TurbAlign (K243655) | Spirair, Inc. | 2025-07-11 |
| Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) (K243280) | W&H Dentalwerk Buermoos GmbH | 2025-07-03 |
| Neuralytix iD3 System (NTX-9001) (K243636) | Neuralytix, LLC | 2025-06-26 |
| EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) (K250862) | Olympus Medical Systems Corp. | 2025-06-23 |
| FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (K244017) | Fujifilm Corporation | 2025-06-13 |
| ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) (K242852) | Inomed Medizintechnik GmbH | 2025-06-13 |
| Disposable Cytology Brush BC-202D/203D Series (K251279) | Olympus Medical Systems Corporation | 2025-06-12 |
| Portare System (FA-001) (K243639) | Grumpy Innovation, Inc. | 2025-06-05 |
| Disposable Balloon Catheter B5-2C (K250118) | Olympus Medical Systems Corporation | 2025-06-04 |
| Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable Biopsy Forceps (FB-231D); Disposable Biopsy Forceps (FB-241D) (K250957) | Olympus Medical Systems Corporation | 2025-05-30 |
| Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (K250215) | Cochlear | 2025-05-29 |
| Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US (K243497) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-05-29 |
| Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1. (K242793) | Shenzhen Insighters Medical Technology Co., Ltd. | 2025-05-28 |
| LumiRex Bronchoscope (K243541) | Contra Healthcare Solutions, LLC | 2025-04-30 |
| Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) (K250256) | Aventamed Dac | 2025-04-28 |
| contact forte Alpha (K243041) | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 |
| Sonu (K242214) | Sound Health Systems, Inc. | 2025-04-24 |
| Disposable Grasping Forceps FG-52D/FG-54D (K250263) | Olympus Medical Systems Corp. | 2025-03-31 |
| Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (K250210) | Scivita Medical Technology Co., Ltd. | 2025-03-19 |
| Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) (K242010) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-03-14 |
| Disposable Cytology Brush (AF series) (K241679) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-03-04 |
| VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (K243380) | Olympus Medical Systems Corporation | 2025-03-03 |
| DUTAU-NOVATECH® (K242324) | Novatech SA | 2025-02-06 |
| Nuance Audio Hearing Aid Software (K243150) | Luxottica Group S.P.A. | 2025-01-31 |
| MONARCH™ Platform (MON-000008) (K243219) | Auris Health, Inc. | 2025-01-23 |
| mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (K241261) | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 |
| mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (K241142) | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 |
| mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (K241269) | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 |
| Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL (K242416) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-16 |
| FirstFit Surgical Kit (K240763) | Freudenberg Medical, LLC | 2024-12-18 |
| Bioscope Neuromonitor Device (K233001) | Biosys Biyomedikal Muhendislik San. VE Tic. A.S. | 2024-12-13 |
| Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) (K241612) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-29 |
| Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (K240289) | Scivita Medical Technology Co., Ltd. | 2024-10-23 |
| Ion Endoluminal System (IF 1000) (K242070) | Intuitive Surgical, Inc. | 2024-09-24 |
| MonoStereo (K234096) | Medicaltek Co., Ltd. | 2024-09-19 |
| Hearing Aid Feature (HAF) (DEN230081) | Apple, Inc. | 2024-09-12 |
| EARP Nerve Cuff Electrode (K241917) | Retropsoas Technologies, LLC | 2024-07-31 |
| MISTI Silicone Implant (K241150) | Keosan Trading Co. | 2024-07-24 |
| Lightin System, Lightin, Lightin Generator (K232177) | Solmedix Co., Ltd. | 2024-07-10 |
| Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS (K240614) | Oticon Medical AB | 2024-07-10 |
| OtoNova/OtoNova Pro (K234095) | Otodynamics | 2024-06-21 |
| BroncTru™ Transbronchial Access Tool (K232601) | Broncus Medical, Inc. | 2024-05-31 |
| Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) (K232646) | Cook Biotech Incorporated | 2024-05-24 |
| Solo+ Tympanostomy Tube Device (TTD) (K232702) | Aventamed Dac | 2024-05-20 |
| Silk Voice (SMI-04) (K240919) | Sofregen Medical | 2024-05-03 |
| MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box (K234113) | Medimaging Integrated Solution, Inc (Miis) | 2024-05-01 |
| Rhinolaryngoscope system (K232435) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-04-26 |
| BioStar Single Use Transbronchial Aspiration Needle (K232038) | Broncus Medical, Inc. | 2024-04-26 |